(194 days)
Not Found
No
The summary describes data acquisition and monitoring but does not mention any processing or analysis using AI/ML techniques.
No.
The device is used for monitoring and measuring muscle activity, range of motion, and strength, which are diagnostic or assessment functions, not therapeutic.
Yes
The device is used for monitoring and recording physiological data (electromyography, motion, muscle strength) of the human body, specifically for surface electromyography with range of motion tracking, functional capacity, and grip strength measuring. This aligns with the definition of a diagnostic device as it gathers information about the body's state. Its use in medical environments, rehabilitation clinics, and for employee evaluation further supports its diagnostic purpose.
No
The device description explicitly states it consists of "a number of sensors to be connected to various parts of the human body" and a "customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data." These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Comprehensive Neuromuscular Profiler directly measures physiological signals from the human body (surface electromyography, range of motion, grip strength). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes monitoring and measuring physical parameters of the body, not analyzing biological samples.
Therefore, this device falls under the category of a physiological monitoring system rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CNMPs primary intended use is for muscular injury testing. It strives to achieve this goal through non-invasive testing, using range-of-motion and functional capacity integration, as well as using standard EMG sensors. The CNMP is specifically designed to testing the cervical, thoracic and the upper and lower extremities. It observes muscle functioning and characteristics. These functions and characteristics include muscle tone, fatigue, and a number of activities which take place in the muscle. The CNMP can be used in a number of arenas, such as sports medicine, rehabilitation clinics, employee evaluation, and litigation.
Surface electromyography with range of motion tracking, functional capacity and grip strength measuring.
Product codes
IKN
Device Description
The Comprehensive Neuromuscular Profiler is a muscle and range of motion monitoring system that is portable, stand-alone and in a convenient package suitable for use in a medical environment. The system consists of a number of sensors to be connected to various parts of the human body which will be fed into a customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data. The conditioned data will then be sent to the notebook computer (PC) that is connected to the enclosure.
The system will be capable of monitoring and recording data from electromyography (EMG) sensors connected to various muscle groups in the human body. During the acquisition of EMG signals, the system will simultaneously acquire motion of the body and/or muscle strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic and the upper and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical environment
sports medicine, rehabilitation clinics, employee evaluation, and litigation.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).
0
510(k) Number: K031995 Section E: 510(k) Summary
Submitted by: Medical Technologies Unlimited, Inc. 9495 Sunset Drive Suite B282 Miami, FL 33173 Telephone: 305-595-7177 Fax: 305-595-7178
June 20, 2003 Date Prepared: Contact Name: Marco Vitiello, M.D. Product Trade Name: Comprehensive Neuromuscular Profiler Classification Name: Diagnostic Eletromyograph (890.1375)
List of Predicate Devices to which we claim substantial equivalence
Description of Device
The Comprehensive Neuromuscular Profiler is a muscle and range of motion monitoring system that is portable, stand-alone and in a convenient package suitable for use in a medical environment. The system consists of a number of sensors to be connected to various parts of the human body which will be fed into a customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data. The conditioned data will then be sent to the notebook computer (PC) that is connected to the enclosure.
The system will be capable of monitoring and recording data from electromyography (EMG) sensors connected to various muscle groups in the human body. During the acquisition of EMG signals, the system will simultaneously acquire motion of the body and/or muscle strength.
Image /page/0/Figure/11 description: The image shows a block diagram of a system. The system starts with a block labeled "Patient", which is connected to a block labeled "Sensors". The "Sensors" block is connected to a block labeled "Signal Conditioning", which is connected to a block labeled "Analog to Digital Conversion". Finally, the "Analog to Digital Conversion" block is connected to a block labeled "Data Transfer".
Intended Use of Device
The CNMPs primary intended use is for muscular injury testing. It strives to achieve this goal through non-invasive testing, using range-of-motion and functional capacity integration, as well as using standard EMG sensors. The CNMP is specifically designed to testing the cervical, thoracic and the upper and lower extremities. It observes muscle functioning and characteristics. These functions and characteristics include muscle tone, fatigue, and a number of activities which take place in the muscle. The CNMP can be used in a number of arenas, such as sports medicine, rehabilitation clinics, employee evaluation, and litigation.
1
The CNMP and the predicate systems both use a range of motion device in combination with functional capacity devices and EMG sensors to obtain similar data. Like the predicate systems, the CNMP uses an off-the-shelf grip strength sensor and an off-the-shelf, standard load cell-based pinch strength sensor. The off-the-shelf ROM device used by the CNMP allows a more accurate method of data acquisition, and it provides more freedom for the patient. The EMG system used by the CNMP covers a greater frequency range and allows for a more substantial amount of signal filtering and conditioning through noise reduction and increased resolution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
JAN - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Technologies Unlimited, Inc. c/o Ms. Angela Morris ALM Consulting 7538 Bear Canyon Road, NE Albuquerque, New Mexico 87109
Re: K031995
Trade/Device Name: Comprehensive Neuromuscular Profiler Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: IKN Dated: October 8, 2003 Reccived: October 9, 2003
Dear Ms. Morris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstatc commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Angela Morris
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K031995 510(k) Number (if known):
Comprehensive Neuromuscular Profiler Device Name:
Indications For Use:
Surface electromyography with range of motion tracking, functional capacity and grip strength measuring.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Officelet fficelot Device Evaluation (ODE)
ivision Sign-Off)
Division of Ger eral, Restative
and Neurological Devices
Numbe K031995
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